Paris (France), 26 October 2023
Ipsen (Euronext: IPN; ADR: IPSEY), a global
specialty-driven biopharmaceutical company, today presents its
sales performance for the year to date and the third quarter of
2023.
|
YTD 2023 |
YTD 2022 |
% change |
Q3 2023 |
Q3 2022 |
% change |
€m |
€m |
Actual |
CER1 |
€m |
€m |
Actual |
CER1 |
Oncology |
1,744.1 |
1,767.2 |
-1.3% |
0.8% |
574.5 |
603.1 |
-4.7% |
0.8% |
Neuroscience |
489.0 |
407.7 |
19.9% |
24.5% |
164.8 |
160.7 |
2.5% |
13.7% |
Rare Disease |
76.0 |
33.6 |
n/a |
n/a |
33.2 |
11.0 |
n/a |
n/a |
Total Sales |
2,309.1 |
2,208.5 |
4.6% |
7.1% |
772.4 |
774.8 |
-0.3% |
6.5% |
Sales and pipeline highlights
- Total-sales
growth in the year to date of 7.1% at CER1, or 4.6% as reported,
driven by the performance of the growth platforms2, up by 16.1%1,
with Dysport® (abobotulinumtoxinA) up by 24.7%1 and Cabometyx®
(cabozantinib) up by 24.4%1, respectively. The performance included
contributions from new medicines Bylvay® (odevixibat), Tazverik®
(tazemetostat) and Sohonos® (palovarotene)
- Further pipeline progress,
including the regulatory approval and launch in the U.S. of
Sohonos® in Rare Disease and initial results from the CONTACT-02
Phase III trial of Cabometyx® plus atezolizumab in Oncology
David Loew, Chief Executive Officer,
commented:“Ipsen’s strategic success has been reflected in
further sales and pipeline progress so far this year. Our portfolio
has performed well across the three therapy areas, driven by
strengthened commercial execution and the results of our
external-innovation strategy. Based on the solid sales momentum,
today we are confirming our guidance for the full year.
Further good news from the pipeline, including
the regulatory approval of Sohonos in the U.S., continue to provide
additional options for patients with real unmet medical needs. In
the final quarter of the year, we look forward to regulatory steps
for elafibranor in primary biliary cholangitis, as well as sharing
further details on sustainable growth opportunities across our
portfolio and pipeline at our forthcoming capital-markets day.”
Full-year 2023 guidanceIpsen
has confirmed its financial guidance for FY 2023:
- Total-sales growth greater than
6.0%, at constant exchange rates. Based on the average level of
exchange rates in September 2023, an adverse impact on total
sales of around 3.5% from currencies is expected
- Core operating margin greater than
30% of total sales
Pipeline development
In August 2023, it was announced that the U.S.
Food and Drug Administration (FDA) had approved Sohonos, the first
and only treatment for people with fibrodysplasia ossificans
progressiva.
It was also announced that the global CONTACT-02
pivotal Phase III trial of Cabometyx plus atezolizumab in
metastatic castration-resistant prostate cancer met one of two
primary endpoints, demonstrating a statistically significant
improvement in progression-free survival at the primary
analysis.
In October 2023, the European Medicines Agency's
(EMA) Committee for Orphan Medicinal Products confirmed its
negative opinion recommending not to maintain the orphan
designation for Bylvay in Alagille syndrome (ALGS). This was
despite a positive opinion from the Committee for Medicinal
Products for Human Use in July 2023. To maintain Bylvay’s orphan
designation in the approved treatment of progressive familial
intrahepatic cholestasis, Ipsen is planning to resubmit to the EMA
under a new brand name for the treatment of ALGS by the end of
2023.
Galderma partnership
In September 2023, the Arbitral Tribunal of the
International Chamber of Commerce issued a final decision following
a difference of opinion on the regulatory-submission strategy for
the liquid botulinum toxin type A, QM1114. In October 2023, Ipsen
announced that its partner, Galderma, had received a Complete
Response Letter from the U.S. FDA related to its Biologics License
Application for QM1114.
A second arbitration proceeding, related to the
territorial scope of the Dysport/Azzalure® aesthetics’ partnership,
is anticipated to conclude next year.
AASLD callTo accompany the
presentation of the ELATIVE Phase III trial results at the American
Association for the Study of Liver Diseases (AASLD) 2023 Annual
World Congress, Ipsen plans to host a conference call for analysts
and investors on 14 November 2023, at 4.30pm CET. Participants can
access the call and its details by registering here; webcast
details can be found here. A recording will be available on
ipsen.com.
Capital-markets dayThe Company
is planning to host a capital-markets event, starting at 12.30pm
GMT on 7 December 2023 in London. The event will be webcast live
and details will be available on ipsen.com in due course. In-person
attendance will be by invitation only.
CalendarIpsen intends to
publish its full-year and fourth-quarter results on 8 February
2024.
Conference call: YTD 2023A
conference call and webcast for investors and analysts will begin
today at 2pm CET. Participants can access the call and its details
by registering here; webcast details can be found here. A recording
will be available on ipsen.com.
Notes
All financial figures are in € millions (€m).
The performance shown in this announcement covers the nine-month
period to 30 September 2023 (YTD 2023) and the three-month period
to 30 September 2023 (Q3 2023), compared to nine-month period to 30
September 2022 (YTD 2022) and the three-month period to 30
September 2022 (Q3 2022), respectively, unless stated otherwise.
Commentary is based on the performance in YTD 2023, unless stated
otherwise.
IpsenIpsen is a global,
mid-sized biopharmaceutical company focused on transformative
medicines in Oncology, Rare Disease and Neuroscience. With total
sales of €3.0bn in FY 2022, Ipsen sells medicines in over 100
countries. Alongside its external-innovation strategy, the
Company’s research and development efforts are focused on its
innovative and differentiated technological platforms located in
the heart of leading biotechnological and life-science hubs:
Paris-Saclay, France; Oxford, U.K.; Cambridge, U.S.; Shanghai,
China. Ipsen has around 5,300 colleagues worldwide and is listed in
Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I
American Depositary Receipt program (ADR: IPSEY). For more
information, visit ipsen.com.
Contacts |
|
Investors |
|
Craig MarksVice President, Investor Relations+44
(0)7584 349 193 |
Nicolas
BoglerSenior Investor Relations Manager+33 6 52 19 98
92 |
Media |
|
Amy WolfVice President and Head of Corporate Brand
Strategy and Communications+41 79 576 07 23 |
Ioana PiscociuSenior Manager, Global Media
Relations+33 6 69 09 12 96 |
Forward-looking statements
The forward-looking statements, objectives and
targets contained herein are based on Ipsen’s management strategy,
current views and assumptions. Such statements involve known and
unknown risks and uncertainties that may cause actual results,
performance or events to differ materially from those anticipated
herein. All of the above risks could affect Ipsen’s future ability
to achieve its financial targets, which were set assuming
reasonable macroeconomic conditions based on the information
available today. Use of the words ‘believes’, ‘anticipates’ and
‘expects’ and similar expressions are intended to identify
forward-looking statements, including Ipsen’s expectations
regarding future events, including regulatory filings and
determinations. Moreover, the targets described in this document
were prepared without taking into account external-growth
assumptions and potential future acquisitions, which may alter
these parameters. These objectives are based on data and
assumptions regarded as reasonable by Ipsen. These targets depend
on conditions or facts likely to happen in the future, and not
exclusively on historical data. Actual results may depart
significantly from these targets given the occurrence of certain
risks and uncertainties, notably the fact that a promising medicine
in early development phase or clinical trial may end up never being
launched on the market or reaching its commercial targets, notably
for regulatory or competition reasons. Ipsen must face or might
face competition from generic medicine that might translate into a
loss of market share. Furthermore, the research and development
process involves several stages each of which involves the
substantial risk that Ipsen may fail to achieve its objectives and
be forced to abandon its efforts with regards to a medicine in
which it has invested significant sums. Therefore, Ipsen cannot be
certain that favorable results obtained during preclinical trials
will be confirmed subsequently during clinical trials, or that the
results of clinical trials will be sufficient to demonstrate the
safe and effective nature of the medicine concerned. There can be
no guarantees a medicine will receive the necessary regulatory
approvals or that the medicine will prove to be commercially
successful. If underlying assumptions prove inaccurate or risks or
uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements. Other risks
and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including
interest rate and currency exchange rate fluctuations; the impact
of pharmaceutical industry regulation and healthcare legislation;
global trends toward healthcare cost containment; technological
advances, new medicine and patents attained by competitors;
challenges inherent in new-medicine development, including
obtaining regulatory approval; Ipsen's ability to accurately
predict future market conditions; manufacturing difficulties or
delays; financial instability of international economies and
sovereign risk; dependence on the effectiveness of Ipsen’s patents
and other protections for innovative medicines; and the exposure to
litigation, including patent litigation, and/or regulatory actions.
Ipsen also depends on third parties to develop and market some of
its medicines, which could potentially generate substantial
royalties; these partners could behave in such ways which could
cause damage to Ipsen’s activities and financial results. Ipsen
cannot be certain that its partners will fulfil their obligations.
It might be unable to obtain any benefit from those agreements. A
default by any of Ipsen’s partners could generate lower revenues
than expected. Such situations could have a negative impact on
Ipsen’s business, financial position or performance. Ipsen
expressly disclaims any obligation or undertaking to update or
revise any forward-looking statements, targets or estimates
contained in this press release to reflect any change in events,
conditions, assumptions or circumstances on which any such
statements are based, unless so required by applicable law. Ipsen’s
business is subject to the risk factors outlined in its
registration documents filed with the French Autorité des Marchés
Financiers. The risks and uncertainties set out are not exhaustive
and the reader is advised to refer to Ipsen’s 2022 Universal
Registration Document, available on ipsen.com.
1 At constant exchange rates (CER), which excludes any
foreign-exchange impact by recalculating the performance for the
relevant period by applying the exchange rates used for the prior
period.2 Dysport, Decapeptyl® (triptorelin), Cabometyx and Onivyde®
(irinotecan).
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